Background/Purpose: Gluco-corticosteroids (GCs) are frequently used to treat autoimmune disease and their chronic use has long been known to cause adverse events (AEs). The purpose of this study was to examine the relationship between dose of GCs, risk of AEs, and healthcare resource utilization (HRU) in patients with systemic lupus erythematosus (SLE).

Methods: This retrospective study used a US commercial insurance claims database from January 2007 through December 2011. SLE patients were identified using ICD-9 CM code 710.0 from ≥2 outpatient or 1 inpatient claims. Use of oral GCs was examined for 12 months from the date of first observed SLE diagnosis (index date). Patients receiving ≥60 days of GCs were categorized based on their average daily oral dose of prednisolone (or equivalent) as follows: low (≤7.5mg), medium (7.5mg15mg) dose groups. A cohort of SLE patients who did not receive any oral GCs was selected as the reference group. Potential AEs associated with chronic GCs were identified from literature and a total of 36 conditions were examined. HRU of outpatient/emergency department (ED) visits, hospitalizations, prescriptions, and total health costs were examined for 12 months post index date. Rates of AEs were compared with the reference group using Chi-square tests. Trend tests of dose response were conducted for dichotomous variables using Cochran-Armitage test and for continuous variables fitted via generalized linear regression.

Results: We identified 46,785 commercially-insured SLE patients with no GCs use and 5,221, 4,965, and 4,136 patients with low, medium, and high dose of GCs, respectively. Their mean age was 46.8, 47.0, 45.1, and 42.8 years and the proportion of males was 9.2, 9.7, 10.8, and 13.3%, respectively. Some but not all steroid-related AEs were observed at a higher frequency among GCs users than non-users. A positive dose-relationship was observed for myopathy, atherosclerosis, hypertension, heart failure, Cushingoid syndrome, and bacterial infection (all P<0.05). Among the patients receiving GCs, the proportion of patients having ED visit (29.7, 37.7, and 47.0%, P<0.01) and hospitalization (18.3, 24.8, and 42.8%, P<0.01) increased significantly with the dose of GCs. Similar trends were observed in annual average number of non-ED outpatient visits (25.0, 28.8, and 34.5, P<0.01) and non-steroid prescriptions and refills (42.9, 48.3, and 51.4, P<0.01).  The annual average total health costs for the low, medium, and high dose groups of GCs users were $21,815, $27,635, and $45,339, respectively (P<0.01).

Conclusion: Higher dose of GCs is associated with more AEs and greater HRU in SLE. Although the association may be confounded by SLE disease severity, this finding highlights the value of future effective SLE treatments with steroid-tapering effect.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/dose-of-corticosteroid-risk-of-adverse-events-and-healthcare-resource-utilization-in-systemic-lupus-erythematosus/